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VP, Regulatory Affairs, Strategy, Labeling and Operations

12 hours, 29 minutes ago
United States
Full-time
Executive
Compliance Manager
Operations
Apply Now
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised
View All Jobs 18

Description

  • Provide strategic and functional leadership for Regulatory Operations, Regulatory Business Operations, and Labeling.
  • Partner with the Chief Regulatory Officer and regulatory leaders to align operational strategy with regulatory goals.
  • Build an infrastructure that supports innovation, speed, accountability, and compliant global submissions.
  • Lead the integration of artificial intelligence and digital tools across regulatory systems and processes.
  • Establish and maintain regulatory SOPs, work instructions, and desk procedures.
  • Manage, develop, and support a team of team leaders and subject matter experts.
  • Ensure effective resource planning, talent development, and staff augmentation to meet corporate priorities.
  • Promote continuous learning and professional development across the regulatory organization.
  • Support regulatory strategy as needed across development and commercial activities.

Requirements

  • Advanced degree in a scientific discipline such as PharmD, PhD, MD, or MS is required.
  • 15+ years of progressive regulatory experience in the biopharmaceutical industry.
  • Experience leading multidisciplinary regulatory teams.
  • Proven experience in labeling strategy and operations for development and commercial products.
  • Deep understanding of global submission requirements and post-approval obligations.
  • Experience establishing and managing regulatory systems such as Veeva Vault or RIM.
  • Experience creating or governing SOPs, work instructions, and desk procedures.
  • Strong working knowledge of clinical and nonclinical regulatory strategy and interactions with global health authorities.
  • Track record of leading or enabling digital transformation or AI integration in regulatory or adjacent functions.
  • Exceptional leadership, communication, and influencing skills in a matrixed, fast-paced environment.
  • Curiosity and adaptability in adopting AI-powered tools and technologies.
  • Experience in a fast-paced, entrepreneurial environment is preferred.

Benefits

  • Market-leading compensation with a salary range of $345,000 to $400,000 USD.
  • Annual performance bonus and company equity.
  • 401(k) with 100% employer match on the first 3% and 50% on the next 2%.
  • Employee stock purchase program.
  • Comprehensive health coverage with 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • Mental health support through Spring Health, including therapy and coaching sessions.
  • Hybrid work model with flexibility; remote work will also be considered.
  • Unlimited flexible paid time off plus company-paid holidays.
  • Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents.
  • Health savings account with annual employer contributions and flexible spending accounts.
  • Pre-tax commuter benefits, subsidized lunch on in-office days, and referral bonuses.
  • Professional development and career pathing through LinkedIn Learning, LifeLabs, and BetterUp Coaching.

Interested in this position?

Apply directly on the company website

Apply Now

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